Locking guidewire straightener

ABSTRACT

A guidewire straightener assembly ( 50,200,300,400 ) including a guidewire tube ( 56,250,450 ) with a tubular passage therethrough having a first diameter and a distal end including a collar ( 58,260,462 ) having a second diameter larger than the first diameter. A guidewire ( 52,202,402 ) having a third diameter, smaller than the first diameter is disposed within the tubular passage. When a guidewire straightener ( 10,210,410 ) is affixed to the guidewire tube distal end in a first position with its biasing member in the tubular passage, the at least one finger ( 26,216,416 ) is biased by the tubular passage into frictional engagement with the guidewire; when disposed in a second position in the collar, the at least one finger is disposed away from frictional engagement with the guidewire.

CROSS-REFERENCE TO RELATED APPLICATION

The present application is a Divisional of U.S. patent application Ser.No. 10/960,737, filed on Oct. 7, 2004 now U.S. Pat. No. 7,455,660, inturn a Continuation-in-Part of U.S. patent application Ser. No.10/366,247, filed on Feb. 13, 2003 now abandoned, which claims priorityfrom U.S. Provisional Patent Application Ser. No. 60/434,262, filed onDec. 18, 2002.

FIELD OF THE INVENTION

The present invention relates to a catheter guidewire and a method ofretaining a catheter guidewire in a guidewire tube.

BACKGROUND OF THE INVENTION

Catheter guidewires are used to facilitate introduction of a catheterinto a patient. In a typical catheter installation, an insertion site islocated, and an incision is made by the inserting physician at theinsertion site. A syringe is inserted into the patient through theincision to locate the blood vessel, such as a vein, to be catheterized.A flexible metal guidewire is typically inserted through the syringe andinto the blood vessel to further enable the inserting physician toinsert the catheter into the patient. The guidewire typically has a“J-shaped” distal end, so as not to tear into the patient's blood vesselduring insertion. The guidewire is quite flexible so that it can bendwith the contours of the blood vessel, but the flexibility of theguidewire, along with the “J-shape”, can make it difficult for thephysician to insert the distal end of the guidewire into the syringe.Guidewire straighteners are used to straighten out the “J-shape” and toassist the physician in inserting the distal tip of the guidewire intothe syringe for advancement into the blood vessel.

A guidewire is typically stored in a coiled plastic tube, both for easeof physician use and for sterility. However, during shipping, theguidewire can work its way out of the tube, making the guidewire moredifficult to handle and potentially compromising the sterility of theguidewire.

A known guidewire straightener is disclosed in U.S. Pat. No. 5,125,905.This guidewire straightener utilizes a cantilevered extension at theproximal end of the straightener to grasp a guidewire and retain theguidewire in its tube. It is believed by the inventors that the priorart design does not provide sufficient gripping between the straightenerand the guidewire. It is also believed by the inventors that the priorart design may be prone to breakage from fatigue.

It would be beneficial to provide a guidewire straightener that providesincreased gripping between the straightener and the guidewire so thatthe guidewire does not work its way out of the tube, as well as aguidewire straightener that is less prone to breakage from fatigue.

BRIEF SUMMARY OF THE INVENTION

Briefly, the present invention provides a guidewire straightenerassembly. The assembly comprises a guidewire tube including a tubularpassage having a first diameter and a distal end including a collarhaving a second diameter, larger than the first diameter. The assemblyalso includes a guidewire straightener having a distal end, a proximalend having an exterior surface with a diameter sized to fit within theguidewire tube, and a longitudinal passageway sized to accept theguidewire, the passageway extending between the proximal end and thedistal end. The assembly further includes a guidewire having a thirddiameter, smaller than the first diameter, wherein the guidewire isdisposed within the tubular passage and the longitudinal passageway. Theproximal end of the guidewire straightener further includes at least onefinger extending therefrom such that, when the guidewire straightener isdisposed within the guidewire tube in a first position in the tubularpassage, the at least one finger is biased by the tubular passage intofrictional engagement with the guidewire. When the guidewirestraightener is disposed within the guidewire tube in a second positionin the collar, the at least one finger is disposed away from frictionalengagement with the guidewire.

The present invention also provides a catheter guidewire tube comprisinga body having a distal end, a proximal end, and a tube passagewayextending between the distal end and the proximal end, wherein the tubehas a first diameter. The assembly also includes a collar fixedlyconnected to the distal end, wherein the collar comprises a longitudinalpassage having a second diameter, larger than the first diameter, andwherein the collar further comprises a distal opening having a thirddiameter, smaller than the second diameter.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated herein and constitutepart of this specification, illustrate the presently preferredembodiments of the invention, and, together with the general descriptiongiven above and the detailed description given below, serve to explainthe features of the invention. In the drawings:

FIG. 1 is a perspective view of a catheter guidewire straighteneraccording to an embodiment of the present invention.

FIG. 2 is a side elevational view of the catheter guidewire straightenershown in FIG. 1.

FIG. 3 is a sectional view of the catheter guidewire straightener takenalong line 3-3 of FIG. 2.

FIG. 4 is a plan view of a catheter guidewire assembly incorporating thecatheter guidewire straightener shown in FIGS. 1-3.

FIG. 5 is a sectional view of the catheter guidewire assembly takenalong line 5-5 of FIG. 4.

FIG. 6 is a schematic view showing operation of the catheter guidewireassembly during insertion of a guidewire into a patient.

FIG. 7 is a side profile view of a catheter guidewire straightenerassembly according to a second embodiment of the present invention.

FIG. 8 is an enlarged sectional view of the guidewire straightenerassembly of FIG. 7, taken along lines 8-8 of FIG. 9.

FIG. 9 is an enlarged sectional view of the guidewire straightenerassembly of FIG. 7, taken along lines 9-9 thereof.

FIG. 10 is an enlarged sectional view of the guidewire straightenerassembly of FIG. 7, with the guidewire straightener removed from theguidewire tube.

FIG. 11 is a sectional view of a catheter guidewire straightenerassembly according to a third embodiment of the present invention.

FIG. 12 is a sectional view of the catheter guidewire straightenerassembly shown in FIG. 11, with the guidewire straightener removed fromthe guidewire tube.

FIG. 13 is a sectional view of a guidewire straightener assemblyaccording to a fourth embodiment of the present invention.

FIG. 14 is a sectional view of the guidewire straightener assembly ofFIG. 13, with the guidewire straightener disconnected from the guidewiretube.

DETAILED DESCRIPTION OF THE INVENTION

In the drawings, like numerals indicate like elements throughout.Certain terminology is used herein for convenience only and is not to betaken as a limitation on the present invention. The words “proximal” and“distal” refer to directions away from and closer to, respectively, theinsertion tip of the guidewire in the guidewire assembly according tothe present invention. The terminology includes the words abovespecifically mentioned, derivatives thereof, and words of similarimport. The following describes a preferred embodiment of the invention.However, it should be understood based on this disclosure, that theinvention is not limited by the preferred embodiment described herein.

A catheter guidewire straightener 10 according to an embodiment of thepresent invention is shown in FIGS. 1-3. The guidewire straightener 10is comprised of a generally frusto-conically shaped distal end 12 and agenerally cylindrically shaped proximal end 14. A stop collar 16 isdisposed between the distal end 12 and the proximal end 14. Astraightener passageway 18 extends through the guidewire straightener 10between the distal end 12 and the proximal end 14. The straightenerpassageway 18 is sized to allow a guidewire 52, shown in a guidewireassembly 50 in FIG. 4, to pass through the straightener passageway 18with little or no interference. A standard guidewire has a diameter ofapproximately 0.038 inches (approximately 0.97 mm), and the straightenerpassageway 18 has a diameter of approximately 0.05 inches (approximately1.27 mm). Therefore, when the guidewire 52 is inserted into thestraightener passageway 18, a clearance of approximately 0.012 inches(approximately 0.30 mm) is provided between the guidewire 52 and theguidewire straightener 10.

Referring back to FIGS. 1-3, the proximal end 14 of the straightener 10includes first and second diametrically opposed biasing assemblies 20,22, which are each comprised of a lug 24 disposed on a biasing member26, such as a leaf spring. A distance between free ends of each lug 24on the biasing assemblies 20, 22, as shown in FIG. 2, is defined as adiameter “D”.

Each biasing assembly 20, 22, extends longitudinally along the proximalend 14 of the straightener 10, with channels 28, 30 disposed on eitherside of the biasing assemblies 20, 22. The channels 28, 30 allow thelugs 24 and the biasing members 26 to deflect toward the straightenerpassageway 18 when force is applied on the lugs 24 toward thestraightener passageway 18. The biasing members 26 resist such force andbias the lugs 24 away from the straightener passageway 18.

Preferably, the guidewire straightener 10 is constructed from a polymer,such as polypropylene, although those skilled in the art will recognizethat other, suitable materials may be used.

A guidewire assembly 50 incorporating the guidewire straightener 10 ofthe present invention is shown in FIGS. 4 and 5. The guidewire assembly50 is comprised of a guidewire 52 disposed within a tube passageway 54of a guidewire tube 56. The guidewire 52 has a “J-shaped” distal end 53.The tube passageway 54 has an inner diameter “d”. The guidewire tube 56is connected to the proximal end 14 of the guidewire straightener 10.

The guidewire tube 56 is preferably coiled as shown for the ease of theuser. The guidewire 52 is typically approximately 24 inches (61 cm) longand, by coiling the guidewire 52 along with the guidewire tube 56, theuser can more readily handle the guidewire 52 and advance the guidewire52 into the patient.

The guidewire tube 56 includes an open distal end 58, through which theguidewire 52 is advanced, the distal end 58 having a collar with aninner diameter larger than tube passageway diameter “d”. The distal end58 of the guidewire tube 56 is inserted over the proximal end 14 of theguidewire straightener 10, so that the distal end 58 of the guidewiretube 56 and the proximal end of the guidewire straightener 10 engageeach other with a press fit.

The diameter “D” of the lugs 24 is larger than the diameter “d” of thetube passageway 54 so that, as is seen in FIG. 5, the distal end collarof guidewire tube 56 biases the lugs 24 and the biasing members 26 intothe straightener passageway 18. Each lug 24 biases its respectivebiasing member 26 against the guidewire 52 so that the guidewire 52 islongitudinally engaged along a length of the guidewire 52 by the biasingmembers 26. The biasing members 26, in turn, bias the lugs 24 againstthe tube's collar to releasably retain the straightener 10 in the tube56.

Referring now to the guidewire insertion procedure of FIG. 6 during acatheter insertion procedure, an incision 110 is initially made near aninsertion site 112 which is to be aspirated with a syringe or otherintroducer apparatus near or proximate the area to be catheterized. Ifthe catheter is used for hemodialysis and the area to be catheterized isthe internal jugular vein 116, the incision 110 is made in theclavicular triangle region, as shown for example, in FIG. 6. The exactlocation of the incision 110 can be varied by the physician. Inaccordance with the Seldinger technique, a narrow needle 114 connectedto the syringe is inserted through the incision 110 and into the vein116, and the vein 116 is aspirated. The syringe is disconnected from theneedle 114, leaving the needle 114 in the vein 116.

The guidewire 52 is next inserted into the vein 116 through the needle114. To insert the guidewire 52 into the vein 116, the proximal end 14of the straightener 10 is removed from the tube 56. The biasing members26 bias away from the straightener passageway 18, releasing theguidewire 52 from between the biasing members 26. The distal end 53 (seeFIGS. 4 and 5) of the guidewire 52 is then retracted into thestraightener 10 so that the “J-shaped” distal end 53 of the guidewire 52is disposed within the straightener 10. The distal end 12 of thestraightener 10 is then inserted into the proximal end of the needle114. The preferably frusto-conical shape of the distal end 12facilitates insertion of the distal end 12 into the needle 114.

Using thumb 118 and forefinger 120 on the guidewire 52 between thestraightener 10 and the tube 56, the physician advances the guidewire 52through the needle 114 and into the vein 116. Once the guidewire 52 isin place, the tube 56 and the straightener 10 are removed by advancingeach of the tube 56 and the straightener 10 along the guidewire 52 awayfrom the distal end 53 of the guidewire 52 and then off the proximal endof the guidewire 52. Next, the needle 114 is removed by advancing theneedle 114 along the guidewire 52 away from the distal end 53 of theguidewire 52 and then off the proximal end of the guidewire 52. Adilator (not shown) and a tearable sheath (not shown) are introducedover the guidewire 52 and partially into the vein 116. The insertionsite 112 is now ready to accept a catheter assembly (not shown). Atleast one catheter lumen is disposed over the proximal end of theguidewire 52 and advanced toward the distal end 53 of the guidewire 52and into the vein.

An alternate embodiment of a guidewire straightener assembly 200 isshown in FIG. 7. The assembly 200 includes a straightener 210 and aguidewire tube 250. The straightener 210 is partially disposed in thetube 250 and is used to assist the inserting physician in advancing aguidewire 202 from the tube 250 during catheter insertion.

Referring to FIG. 8, the straightener 210 includes a distal end 212 thatis generally conically or frusto-conically shaped. The distal end 212 isshaped to facilitate insertion of the distal end 212 into an introducerdevice, such as an introducer needle (not shown). The straightener 210also includes a proximal end 214 that includes a biasing member 216. Alongitudinal axis 217 extends through the straightener 210. Astraightener passageway 218 extends along the longitudinal axis 217through the straightener 210 between the distal end 212 and the proximalend 214. The passageway 218 has a diameter D₁ that is sized to allow theguidewire 202 to be able to be translated therethrough with a minimalforce during insertion of the guidewire 202 into the patient.

The biasing member 216 includes a plurality of fingers 220 that extendin a proximal direction. While eight fingers 220 are shown in FIG. 9,those skilled in the art will recognize that more or less than eightfingers 220 may be used. Each finger 220 has a connected end 222 that isconnected to the proximal end 214 and a free end 224 that freely extendsaway from the proximal end 214. Each finger 220 has a body portion 226between the connected end 222 and the free end 224 that is biased awayfrom the longitudinal axis 217. The biasing member 216 is dimensionedsuch that, when the biasing member 216 is disposed within the guidewiretube 250, the interior wall of the guidewire tube 250 biases the biasingmember 216 against the guidewire 202.

The guidewire advancer 210 also includes a generally elongated portion230 that extends between the distal end 212 and the proximal end 214.The generally elongated portion 230 extends below the guidewire 202 andis open so that the guidewire 202 is accessible. A generally convexraised portion 232 extends from the generally elongated portion 230 andprovides a thumb rest for advancing the guidewire 202 distally throughthe advancer 210.

The guidewire tube 250 includes a distal end 252 that engages thestraightener 210. The guidewire tube 250 has an inner diameter D₂ thatis sized to allow the proximal end 214 of the straightener 210 to beinserted into the guidewire tube 250. The guidewire tube 250 also has anouter diameter D₃. A cylindrical collar 260 is fixedly connected to thedistal end 252 of the tube 250.

The collar 260 is preferably constructed from a polymer, such aspolypropylene, or some other suitable material. Those skilled in the artwill recognize that the collar 260 may be a separate piece from the tube250, or the collar 260 may be integrally formed with the tube 250. Ifthe collar 260 is a separate piece from the tube 250, the collar 260 isfixedly connected to the tube 250 by known methods, such as by anadhesive, by ultrasonic welding, or other means known in the art forconnecting the collar 260 to the tube 250.

The collar 260 includes a proximal collar end 262 that fits over theexterior of the distal end 252 of the tube 250, seen best in FIG. 8. Thecollar 260 also includes a distal collar end 264, and expands distallyfrom the tube distal end to define a generally enclosed chamber that hasan inner diameter D₄ that is larger than the outer diameter D₃ of thetube 250. The distal collar end 264 includes an opening 265 along thelongitudinal axis 217 that is sized to allow the proximal end 214 of thestraightener 210 to be inserted into the opening 265. The inner diameterD₄ of the distal collar end 264 is sufficiently large to allow thebiasing member 216 to expand within the interior of the distal collarend 264 to allow the biasing member 216 to expand and release theguidewire 202. However, it is preferred that the distal opening 265 issufficiently small such that the biasing member 216 cannot be easilypulled through the distal opening 265 and out of the collar 260.

The collar 260 also includes a tapered portion 266 that tapers from theproximal collar end 262, outward to the distal collar end 264.Preferably, the tapered portion 266 begins at the distal end 252 of thetube 250, although those skilled in the art will recognize that thetapered portion 266 may begin either proximally or distally of thedistal end 252 of the tube 250.

The assembly 200 is provided with the straightener 210 fully insertedinto the tube 250, as shown in FIGS. 7 and 8. In use, the straightener210 is partially removed from the tube 250 by advancing the straightener210 in a distal direction relative to the tube 250. The biasing means216 moves distally from the interior of the tube 250 to the interior ofthe collar 260 to the position shown in FIG. 10. When the plurality offingers 220 enter the interior of the collar 260, the fingers 220 springaway from the guidewire 202, allowing the guidewire 202 to be freelyadvanced from the distal end 212 of the straightener 210 according toknown methods. The straightener 210, however, is not sufficiently movedrelative to the tube 250 so as to pull the proximal end 214 of thestraightener 210 through the distal opening 265 of the collar 260.

After the guidewire 202 is inserted a desired distance into the patient,the guidewire straightener assembly 200 is removed from the guidewire202 by sliding the assembly 200 proximally along the guidewire 202 untilthe guidewire 202 exits the assembly 200. The assembly 200 is discardedand the catheter insertion procedure continues according to steps andprocesses well known in the art.

While the guidewire assembly 200 with the collar 260 fixed to the distalend 252 of the tube 250 is preferred, those skilled in the art willrecognize that a guidewire assembly 300, shown in FIG. 11, that omitsthe collar may be used. The straightener 210 is inserted into the tube250 as shown in FIG. 11, with the fingers 220 biased against theguidewire 202.

In use, the straightener 210 is advanced distally with respect to thetube 250 until the proximal end 214 of the straightener 210 is removedfrom the tube, as show in FIG. 12. The fingers 220 spring away from theguidewire 202, allowing the guidewire 202 to be freely advanced from thedistal end 212 of the straightener 210. The user biases the guidewire202 against the generally convex raised portion 232 and advances his/herthumb in a distal direction, using friction to distally advance theguidewire 202 as well.

After the guidewire 202 is inserted a desired distance into the patient,the guidewire straightener assembly 300 is removed from the guidewire202 by sliding the assembly 300 proximally along the guidewire 202 untilthe guidewire 202 exits the assembly 200. The assembly 300 is discardedand the catheter insertion procedure continues according to steps andprocesses well known in the art.

Yet another embodiment of the present invention is shown in FIGS. 13 and14. A guidewire straightener assembly 400 includes a guidewirestraightener 410 and a guidewire tube 450 that are used to retain anddispense a guidewire 402. A swivel lock assembly 460 releasably connectsthe straightener 410 and the tube 450 to each other.

The straightener 410 includes a distal end 412 that is generallyconically or frusto-conically shaped. The distal end 412 is shaped tofacilitate insertion of the distal end 412 into an introducer device,such as an introducer needle (not shown). The straightener 410 alsoincludes a proximal end 414 that includes a biasing member 416. Alongitudinal axis 417 extends through the straightener 410. Astraightener passageway 418 extends along the longitudinal axis 417through the straightener 410 between the distal end 412 and the proximalend 414. The passageway 418 has a diameter D₁ that is sized to allow theguidewire 402 to be able to be translated therethrough with a minimalforce during insertion of the guidewire 402 into the patient.

The biasing member 416 includes a plurality of fingers 420 that extendin a proximal direction. Similar to the biasing member 216 describedabove and shown in FIG. 9, the biasing member 416 preferably includessix fingers 420. While six fingers 420 are preferred, those skilled inthe art will recognize that more or less than six fingers 420 may beused. Each finger 420 has a proximal end 422 that is connected to theproximal end 414 and a distal end 424 that extends away from theproximal end 414. Each finger 420 has a body portion 426 between theproximal end 422 and the distal end 424 that is biased away from thelongitudinal axis 417. The biasing member 416 is dimensioned such that,when the biasing member 416 is disposed within the guidewire tube 450,the interior wall of the guidewire tube 450 biases the biasing member416 against the guidewire 402, restricting the movement of the guidewire402 within the tube 450.

The straightener 410 includes an annular groove 430 disposed between thedistal end 412 and the proximal end 414. The groove 430 is sized andshaped to allow the distal end of the swivel lock assembly 460 to berotatably attached to the straightener 410, as will be described more indetail later herein.

The guidewire tube 450 includes a distal end 452 that engages thestraightener 410. The guidewire tube 450 has an inner diameter D₂ thatis sized to allow the proximal end 414 of the straightener 410 to beinserted into the guidewire tube 450. The guidewire tube 450 also has anouter diameter D₃. The swivel lock assembly 460 includes a cylindricalcollar 462 that is fixedly connected to the distal end 452 of the tube450 and a swivel lock 470 that is rotatably connected to thestraightener 410.

The collar 462 is preferably constructed from a polymer, such aspolypropylene, or some other suitable material. Those skilled in the artwill recognize that the collar 462 may be a separate piece from the tube450, or the collar 462 may be integrally formed with the tube 450. Ifthe collar is a separate piece from the tube 450, the collar 462 isfixedly connected to the tube 450 by known methods, such as by anadhesive, by ultrasonic welding, or other means known in the art forconnecting the collar 462 to the tube 450. Preferably, the collar 462includes a stop 461 that limits the distance that the collar 462 may beadvanced over the distal end 452 of the tube 450.

The collar 462 includes a distal collar end 464 that includes malethreads 466. The swivel lock 470 includes female threads 472 thatthreadingly engage with the male threads 466. A distal end of the swivellock 470 includes a lip 474 that rotates within the groove 430 in thestraightener 410 to allow the swivel lock 470 to rotate about thelongitudinal axis 417 with respect to the straightener 410.

The assembly 400 is provided with the straightener 410 fully insertedinto the tube 450 and the swivel lock 470 connected to the collar 462,as shown in FIG. 13. In use, the straightener 410 is removed from thetube 450 by rotating the swivel lock 470 relative to the collar 462 andunthreading the female threads 472 from the male threads 466. When theswivel lock 470 is unthreaded from the collar 462, the straightener 410is advanced in a distal direction relative to the tube 450. The biasingmeans 416 moves distally from the interior of the tube 450 to theposition shown in FIG. 14. When the plurality of fingers 420 exits thedistal end 452 of the tube 450, the fingers 420 spring away from theguidewire 402, allowing the guidewire 402 to be freely advanced from thedistal end 412 of the straightener 410 according to known methods.

After the guidewire 402 is inserted a desired distance into the patient,the guidewire straightener assembly 400 is removed from the guidewire402 by sliding the assembly 400 proximally along the guidewire 402 untilthe guidewire 402 exits the assembly 400. The assembly 400 is discardedand the catheter insertion procedure continues according to steps andprocesses well known in the art.

It will be appreciated by those skilled in the art that changes could bemade to the embodiments described above without departing from the broadinventive concept thereof. It is understood, therefore, that thisinvention is not limited to the particular embodiments disclosed, but itis intended to cover modifications within the spirit and scope of thepresent invention as defined by the appended claims.

What is claimed is:
 1. A catheter guidewire tube comprising: a tube bodyhaving a distal end, a proximal end, and a tube passageway extendingbetween the distal end and the proximal end, wherein the tube body has afirst inner diameter, and wherein the tube body is adapted to permitrelative axial movement of a guidewire within the tube body; and acollar fixedly connected to the tube distal end, wherein the collarcomprises a continuous longitudinal passage therethrough, thelongitudinal passage extending distally of the tube body distal end andexpanding to form a generally enclosed chamber having a second innerdiameter, larger than the first inner diameter, and wherein the collarfurther comprises a distal end wall defining a distal opening having afixed third inner diameter during use, smaller than the first innerdiameter wherein the enclosed chamber is sufficiently large to allow abiasing member of a guidewire straightener to expand within the enclosedchamber and the distal opening is sized such that the biasing member isnot easily pulled through the distal opening.
 2. The catheter guidewiretube according to claim 1, wherein the collar is fixedly connected tothe tube body by an adhesive.
 3. The catheter guidewire tube accordingto claim 1, wherein the collar is fixedly connected to the tube body byultrasonic welding.
 4. The catheter guidewire tube according to claim 1,wherein the first inner diameter is sufficiently small to frictionallyengage a proximal end of a guidewire straightener inserted therein. 5.The catheter guidewire tube according to claim 1, wherein the proximalportion of the enclosed chamber is tapered from the second innerdiameter to the tube distal end.